The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.

Device Description

The Rotablator Rotational Angioplasty System uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140,000-190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The burr is driven by a flexible helical drive which has a central lumen through which a guide wire passes. The drive shaft is connected to an air turbine which is powered by compressed air or nitrogen. The guide wire that is used with this system can be separately advanced and steered past an occlusive lesion. The guide wire has a radiopaque spring tip that facilitates its passage through the vasculature, minimizes trauma to the vessel, and makes its progress visible. The sheath covering the drive shaft protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the spinning drive. The advancer functions as a housing for the air turbine and as for the sliding elements that control burr extension. The console monitors and controls the votational speed of the burr and continuously provides the operator with herformance information during the procedure. The console has two modes of operation: a high speed for ablation and a lower speed for catheter exchange. The foot pedal is the on/off control for the advancer air turbine and is mounted in a protective shroud to inhibit accidental actuation. The pedal is fitted with a valve that vents any compressed gas left in the foot pedal hose when the pedal is released, permitting rapid stopping of the burr. The foot pedal also has a toggle switch for activating and deactivating the lower speed catheter exchange. The compressed gas system consists of a regulator mounted on a compressed gas cylinder and a supply hose leading to the control console inlet.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance (HTI Floppy, Floppy II, Standard)	Predicate Performance (Type A, Type C)
Tensile Force (weld joint)	Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates.	Floppy: 315gFloppy II: 364gStandard: 603g	Type A: 182gType C: No Test
Tensile Force (solder joint)	Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates.	Floppy: 1132gFloppy II: 1373gStandard: 1837g	Type A: 2384gType C: No Test
Torque Strength (turns to failure)	Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates.	Floppy: 11.6Floppy II: 9.7Standard: 15	Type A: No TestType C: 18.8
Torqueability (proximal to distal turns)	A 1:1 torque response is desirable (for one revolution of the proximal end, the distal spring tip in the vessel should also rotate once).	Floppy: 1.75 to 1Floppy II: No TestStandard: 2 to 1	Type A: 3.25 to 1Type C: No Test
Tip Flexibility (a: cantilevered 1.5")	Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates.	Floppy: 15.7 mmFloppy II: 20.7 mmStandard: 14 mm	Type A: 6.0 mmType C: 19.0 mm
Tip Flexibility (b: cantilevered 3.1")	Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates.	Floppy: 44.0 mmFloppy II: 47.5 mmStandard: No Test	Type A: 25.1 mmType C: 20.0 mm
Tip Flexibility (c: cantilevered 6.1")	Not explicitly stated as a numerical criterion, but the performance is presented to be compared against predicates.	Floppy: 97.8 mmFloppy II: 102.9 mmStandard: No Test	Type A: 76.2 mmType C: 71.1 mm
Wear Test	Success criteria: (1) guide wire does not fail catastrophically, and (2) at the end of a two-minute test, advancer speed ≥ 150,000 RPM.	All wire configurations passed wear test.	Not explicitly stated, implied to be previously met by predicate devices.
Heart Model (Qualitative)	N/A (qualitative assessment of pushability and steerability).	All HTI wires were found more maneuverable than the Types A and C.	N/A (predicate served as comparison baseline).
Clinical Performance	Complication rates associated with HTI guide wires are not significantly different from Types A and C guide wires (with specified exceptions not related to the guide wire). Safety and efficacy conclusions for coronary use also apply to peripheral use.	Descriptive statistical analysis showed no significant difference in complication rates (with exceptions). One guide wire fracture observed.	Not explicitly detailed but serves as the baseline for comparison.

2. Sample Sizes Used for the Test Set and Data Provenance

Clinical Test Set Sample Size: 147 sequentially enrolled patients.
Data Provenance: The study was a clinical investigation conducted between July 1994 and December 1994. It's a prospective study given the enrollment period. The geographic origin is not explicitly stated, but the company is based in Redmond, WA, USA, suggesting a US-based study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document describes a clinical investigation with patient outcomes and complication rates. The "ground truth" here is the clinical outcome observed in patients during the angioplasty procedure.
The number and qualifications of clinicians involved in the patient procedures and outcome assessment are not explicitly stated in the provided text.
The study references "Ellis, et al, Circulation, Vol 89, No 2, Feb 1994. Relation of Clinical Presentation, Stenosis, Morphology, and Operator Technique to the Procedural Results of Rotational Atherectomy Facilitated Angioplasty," suggesting that clinical practice and established medical literature inform the understanding of outcomes.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the clinical outcomes. It describes standard clinical follow-up and descriptive statistical analysis of complication rates.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study, as typically understood in AI-assisted diagnostics (i.e., comparing human readers with and without AI assistance), was not performed. This study is for a medical device (guide wire) and focuses on its safety and effectiveness compared to predicate devices, not an AI model's impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is a medical device, not an algorithm. The "standalone" performance refers to the device's intrinsic mechanical properties and clinical outcomes when used by clinicians. The bench tests (tensile force, torque strength, flexibility, wear test) represent aspects of standalone device performance.

7. The Type of Ground Truth Used

Clinical Outcomes/Patient Data: For the clinical study, the ground truth is based on observed patient outcomes, complication rates, and the assessment of guide wire performance during actual procedures (e.g., guide wire fracture). This includes both objective measures (complication rates) and qualitative clinical assessments (e.g., maneuverability in the heart model).
Engineering Specifications/Bench Test Results: For the in-vitro tests, the ground truth is the direct measurement of physical properties (e.g., grams of tensile force, turns to failure for torque strength, mm for tip flexibility) under controlled laboratory conditions, against established engineering standards or comparative predicate device performance.

8. The Sample Size for the Training Set

This pertains to an AI/ML context. Since this is a submission for a physical medical device (a guide wire), there is no "training set" in the AI sense. The design and validation of the guide wire are based on engineering principles (bench testing) and clinical trials, not machine learning.

9. How the Ground Truth for the Training Set Was Established

As there is no AI training set, this question is not applicable.

Summary

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TABLE OF CONTENTS 510(k) SUMMARY

A.	. 2Introduction
B.	2Device Description
C.	Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
D.	Comparison to Predicate Device4
E.	In Vitro Tests5
F.	Clinical Tests1

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K954604

510(k) for Peripheral Rotablator® Rotational Angloplasty System with the HTI Guide Wire Line

510(k) SUMMARY

Introduction A.

This 510(k) is for a new line of guide wires which are designed for use with the Rotablator• Rotational Angioplasty System.

Submitter:	Heart Technology, Inc.17425 N.E. Union Hill RoadRedmond, WA 98052
Contact:	Diane JohnsonPhone: (206) 556-1541Fax: (206) 558-1400
Device Common Name:	Rotational Angioplasty SystemGuide Wires
Device Proprietary Name:	Rotablator Rotational Angioplasty SystemRotablator System's Guide Wire Line: HTI Floppy; HTIFloppy II; HTI Standard
Classification Name:	Catheter, Peripheral, Atherectomy (per 21 CFR 870.4875)Guide Wire, Angiographic, Accessory
Classification Panel:	Cardiovascular
Manufacturing Facilities:	Heart Technology Manufacturing, Inc.2515 140th Avenue NE.Bellevue, WA 98005and17425 N.E. Union Hill RoadRedmond, WA 98052

Device Description 8.

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The drive shaft is connected to an air turbine which is powered by compressed air or nitrogen.

The guide wire that is used with this system can be separately advanced and steered past an occlusive lesion. The guide wire has a radiopaque spring tip that facilitates its passage through the vasculature, minimizes trauma to the vessel, and makes its progress visible.

The sheath covering the drive shaft protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the spinning drive.

The advancer functions as a housing for the air turbine and as for the sliding elements that control burr extension.

The console monitors and controls the votational speed of the burr and continuously provides the operator with herformance information during the procedure. The console has two modes of operation: a high speed for ablation and a lower speed for catheter exchange.

The foot pedal is the on/off control for the advancer air turbine and is mounted in a protective shroud to inhibit accidental actuation. The pedal is fitted with a valve that vents any compressed gas left in the foot pedal hose when the pedal is released, permitting rapid stopping of the burr. The foot pedal also has a toggle switch for activating and deactivating the lower speed catheter exchange.

The compressed gas system consists of a regulator mounted on a compressed gas cylinder and a supply hose leading to the control console inlet.

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510(k) for Peripheral Rotablator® Rotational Angloplasty System with the HTI Page 4 Guide Wire Line

Intended Use C.

Comparison to Predicate Device D.

The Rotablator system's new HTI guide wires are substantially equivalent to the currently marketed Type A and Type C guide wires. The differences in the HTI wires compared to the currently marketed Types A and C are summarized in Table 1. The indications for use remain the same. No change to the Rotablator advancericatheter or the console is being proposed.

Feature	Types A and C	HTI
Wire Profile	Linear taper in the distal1.60"	Compound tapered profilein the distal 18.0"
Wire Material	304 Stainless Steel	304 Stainless Steel
Spring Tip Material	Pt-8%W alloy	Pt-8%W alloy orPt-10%Ni alloy
Spring Tip Length	Type A 1.05"Type C 1.40"	Floppy .85"Floppy II 1.10"Standard .85"
Spring Tip InnerDiameter	.0090"	.0055 to .0060"
Spring Tip OuterDiameter	0.017"	0.014"

Table 1. Design Comparison of Types A and C, and HTI Guide Wires

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510(k) for Peripheral Rotablator® Rotational Angioplasty System with the HTI Page 5 Guide Wire Line

In Vitro Tests E.

A series of bench tests were done that characterize the performance of the HTI guide wires in a clinical setting. The results of these tests indicate that the HTI guide wires are safe and reliable. Test results are summarized in Table 2.

In addition to the tests summarized in Table 2, toxicity tests were completed on a Pt-10%Ni alloy because this material was chosen as an alternative to the Pt-8%W alloy currently used for the spring tips in HTI's guide wires.

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	Floppy	Floppy II	Standard	Type A	Type C
Tensile Force (grams)a) weld jointb) solder joint	a) 315b) 1132	a) 364b) 1373	a) 603b) 1837	a) 182b) 2384	a) No Testb) No Test
Torque Strength (turns to failure)	11.6	9.7	15	No Test	18.8
Torqueability1(proximal to distal turns)	1.75 to 1	No Test	2 to 1	3.25 to 1	No Test
Tip Flexibility (mm)a) cantilevered 1.5"; force =.18 gmb) cantilevered 3.1"; force =.18 gmc) cantilevered 6.1"; force =.16 gm	a) 15.7b) 44.0c) 97.8	a) 20.7b) 47.5c) 102.9	a) 14b) No Testc) No Test	a) 6.0b) 25.1c) 76.2	a) 19.0b) 20.0c) 71.1
Wear Test	All wire configurations passed wear test. Success criteria: (1) guide wire does not fail catastrophically, and (2) at end of two minute test, advancer speed ≥ 150,000 RPM.
Heart Model	In this qualitative assessment of pushability and steerability the Floppy and Floppy II were compared to Type C, and the Standard was compared to Type A. All A Plus wires were found more maneuverable than the Types A and C.

Table 2. Engineering Test Comparison of Types A and C, and HTI Guide Wires

A one-to-one torque response is desirable, that is, for one revolution of the proximal end (outside the body), the distal spring tip in the vessel should also rotate once.

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Clinical Tests ட்

The clinical investigation included 147 sequentially enrolled patients with coronary artery disease between July 1994 and December 1994. The inclusion and exclusion criteria are consistent with the Investigational Plan previously submitted in G940032. The contraindications and precautions are consistent with the approved Instructions for Use for the Rotablator System. The patients' demographic characteristics are similar to those in the study involving the originally approved guide wires, although the current population includes patients with more pronounced risk factors.

Descriptive statistical analysis showed that the complication rates associated with the use of the HTI guide wires and the Types A and C guide wires are not significantly different with the exception of spasm, abrupt closure post catheterization lab, and access site bleeding of significance. These complications are not considered to be related to the guide wire. It may be hypothesized that the increase in these complications can be attributed to the patient population characteristics. In general, the Rotablator system is currently utilized more often to treat complex lesions (as compared to the original PMA population). It has been shown that both procedural success and complications are a function of lesion classification.2 Because lesions were characterized differently in the two studies, it is not possible to directly compare lesion dassification between the current study and the previous study. However, the lesion characteristics indicate that the current lesions would fall into a higher lesion classification than those in the original PMA population.

No patients were discontinued from the study. There was one guide wire fracture during the investigation. Although these clinical data are from coronary use of the

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Ellis, et al, Circulation, Vol 89, No 2, Feb 1994. Relation of Clinical Presentation, Stenosis, Morphology, and Operator Technique to the Procedural Results of Rotational Atherectorny Facilitated Angioplasty.

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510(k) for Peripheral Rotablator® Rotational Angloplasty System with the HTT Guide Wire Line

Rotablator system, the conclusions of safety and efficacy also apply to the peripheral Rotablator system since the coronary procedure represents a worst case situation.
Rotablator system since the coronary procedure represents a worst case situation.

The preceding summaries demonstrate that the design of the HTI guide wires is a The preceding summance control.
robust, and that they are capable of performing satisfactorily with the Rotablator robust, and that they are capable of the Type A and Type A and Type C guide wires that are currently used.

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).